BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKE FLOW 2

    MDR report key: 7650467 · Received June 28, 2018

    Report

    Report Number
    MW5078166
    Event Type
    Malfunction
    Date Received
    June 28, 2018
    Date of Event
    June 27, 2018
    Report Date
    June 27, 2018
    Manufacturer
    STRYKER CORP.
    Product Code
    GCX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING LAPAROSCOPIC CHOLECYSTECTOMY, STRYKER SUCTION IRRIGATOR (REF 250-070-500; LOT 18047FG2) QUIT WORKING. SUCTION MACHINE FILTER REPLACED WITHOUT RESOLUTION. WHEN PRESSING "SUCTION BUTTON", HAND PIECE DOES NOT REACT - NO SOUND OR FUNCTION. IRRIGATOR REPLACED (DIFFERENT LOT) WITH NO ISSUES. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491460 STRYKE FLOW 2 STRYKER SUCTION IRRIGATOR GCX STRYKER CORP. 250-070-500 18047FG2

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR